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510(k) K811993

RADIOIMMUNOASSAY, FOLLICLE STIMULATING by Endocrine-Metabolic Center — Product Code CGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1981
Date Received
July 14, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Follicle-Stimulating Hormone
Device Class
Class I
Regulation Number
862.1300
Review Panel
CH
Submission Type

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  • K810948 — RADIOIMMUNOASSAY THYROID STIM. HORM. KIT (April 17, 1981)
  • K810351 — RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE (February 23, 1981)
  • K800188 — EMC-M-180, T3 UPTAKE - 100 TUBES (February 13, 1980)
  • K800187 — EMC-M-175, THYROXINE - 100 TUBES (February 13, 1980)
  • K790602 — RIA, DIGNXIN-125-I (July 30, 1979)
  • K790630 — RIA, INSULIN, DOUBLE ANTIBODY (July 24, 1979)

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  • K964693 — ELECSYS FSH ASSAY (December 16, 1996)